Trial Outcomes & Findings for Safety and Efficacy Study of WRSS1, a Shigella Sonnei Vaccine Candidate (NCT NCT01080716)
NCT ID: NCT01080716
Last Updated: 2018-11-13
Results Overview
Overview of AEs highlighting all AEs, withdrawals and deaths related to AEs
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2018-11-13
Participant Flow
Volunteers were recruited by contacting people from a list of potential volunteers from previous studies, by friend to friend contact, by internal announcement or by presentation booth in the university, community or blood donor sites. Recruitment and screening was performed by the staff at the Vaccine Trial Center, Mahidol University.
Part 1 - total of 20 volunteers (14 vaccinees and 6 controls) Part 2 - was started approximately 60 days after WRSS1 vaccination. 10 vaccinees from part 1 and 10 naïve controls
Participant milestones
| Measure |
Arm 1: WRSS1 Vaccine
WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S. sonnei
|
Arm 1: Placebo Vaccine
Placebo comparator
|
Arm 2: S. Sonnei 53G
10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given S. sonnei 53G
|
Arm 2: S. Sonnei 53G (Naive Subjects)
10 naïve controls given S. sonnei 53G
|
|---|---|---|---|---|
|
Part 1
STARTED
|
14
|
6
|
0
|
0
|
|
Part 1
COMPLETED
|
13
|
6
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
10
|
10
|
|
Part 2
COMPLETED
|
0
|
0
|
10
|
10
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: WRSS1 Vaccine
WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S. sonnei
|
Arm 1: Placebo Vaccine
Placebo comparator
|
Arm 2: S. Sonnei 53G
10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given S. sonnei 53G
|
Arm 2: S. Sonnei 53G (Naive Subjects)
10 naïve controls given S. sonnei 53G
|
|---|---|---|---|---|
|
Part 1
Physician Decision
|
1
|
0
|
0
|
0
|
Baseline Characteristics
1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
Baseline characteristics by cohort
| Measure |
Part 1/Arm 1 of Study: WRSS1 Vaccine
n=13 Participants
WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei
Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1
|
Part 1/Arm 2 of Study: Placebo Vaccine
n=6 Participants
Placebo comparator
|
Part 2/Arm 1 of Study: S. Sonnei 53G
n=10 Participants
10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
|
Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
n=10 Participants
10 subjects (naïve controls) given S. sonnei 53G
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants • 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
|
3 Participants
n=7 Participants • 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
|
5 Participants
n=5 Participants • 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
|
2 Participants
n=4 Participants • 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
|
18 Participants
n=21 Participants • 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants • 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
|
3 Participants
n=7 Participants • 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
|
5 Participants
n=5 Participants • 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
|
8 Participants
n=4 Participants • 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
|
21 Participants
n=21 Participants • 1 subject withdrawn due to diarrhea and mucus in stool prior to vaccination
|
|
Region of Enrollment
Thailand
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
39 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsOverview of AEs highlighting all AEs, withdrawals and deaths related to AEs
Outcome measures
| Measure |
Part 1/Arm 1 of Study: WRSS1 Vaccine
n=13 Participants
WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei
Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1
|
Part 1/Arm 2 of Study: Placebo Vaccine
n=6 Participants
Placebo comparator
|
Part 2/Arm 1 of Study: S. Sonnei 53G
n=10 Participants
10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
|
Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
n=10 Participants
10 subjects (naïve controls) given S. sonnei 53G
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
All Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
All Adverse Events
|
9 Participants
|
5 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events
Withdrawals Due to Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 0-5 daysPopulation: Number of participants in vaccine and controls following the challenge who experienced one or more clinical disease criteria
Study Part 2-Frequency of Shigella induced clinical disease defined as one or more of diarrhea, dysentery or fever in vaccinees and controls following challenge with S. sonnei 53G. Transmissibility of disease will be evaluated by the presence of fecal shedding in control subjects.
Outcome measures
| Measure |
Part 1/Arm 1 of Study: WRSS1 Vaccine
n=10 Participants
WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei
Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1
|
Part 1/Arm 2 of Study: Placebo Vaccine
n=10 Participants
Placebo comparator
|
Part 2/Arm 1 of Study: S. Sonnei 53G
10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
|
Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
10 subjects (naïve controls) given S. sonnei 53G
|
|---|---|---|---|---|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Headache · Yes
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Headache · No
|
8 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Meet Criteria of Clinical Disease · No
|
7 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Meet Criteria by External Review · Yes
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Meet Criteria by External Review · No
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Shedding S.sonnei (Fecal) · Yes
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Shedding S.sonnei (Fecal) · No
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Diarrhea · Yes
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Diarrhea · No
|
9 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Dysentery · Yes
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Dysentery · No
|
8 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Fever · Yes
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Fever · No
|
9 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Abdominal Pain · Yes
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Abdominal Pain · No
|
9 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Tenesmus · Yes
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Tenesmus · No
|
9 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Nausea · Yes
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Nausea · No
|
9 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Vomiting · Yes
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Vomiting · No
|
10 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Myalgia · Yes
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Myalgia · No
|
8 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Joint Pain · Yes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Joint Pain · No
|
10 Participants
|
10 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Dizziness · Yes
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Dizziness · No
|
8 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Anorexia · Yes
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Anorexia · No
|
9 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Malaise · Yes
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Malaise · No
|
7 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Shigella Induced Clinical Disease in Part 2
Meet Criteria of Clinical Disease · Yes
|
3 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, and 28Population: Count of subjects in Parts 1 and 2 with normal and abnormal clinical laboratory values after samples taken on days 1, 7, 14, and 28. Abnormal lab values are determined clinically significant by the PI. Results were not presented per arm in the FCSR, but were instead presented as parts 1 and 2 of the study.
Count of subjects in Parts 1 and 2 with normal and abnormal clinical laboratory values after samples taken on days 1, 7, 14, and 28. Abnormal lab values are determined clinically significant by the PI
Outcome measures
| Measure |
Part 1/Arm 1 of Study: WRSS1 Vaccine
n=20 Participants
WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei
Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1
|
Part 1/Arm 2 of Study: Placebo Vaccine
n=20 Participants
Placebo comparator
|
Part 2/Arm 1 of Study: S. Sonnei 53G
10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
|
Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
10 subjects (naïve controls) given S. sonnei 53G
|
|---|---|---|---|---|
|
Count of Subjects With Normal and Abnormal Clinical Laboratory Values During Parts 1 and 2 of Study
Not Clinically Abnormal
|
20 Participants
|
19 Participants
|
—
|
—
|
|
Count of Subjects With Normal and Abnormal Clinical Laboratory Values During Parts 1 and 2 of Study
Clinically Abnormal
|
0 Participants
|
1 Participants
|
—
|
—
|
Adverse Events
Part 1/Arm 1 of Study: WRSS1 Vaccine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 1/Arm 2: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2/Arm 1 of Study: S. Sonnei 53G
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1/Arm 1 of Study: WRSS1 Vaccine
n=13 participants at risk
WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei
Part 1/Arm 1 of Study: WRSS1 vaccine: Single, oral dose of WRSS1
|
Part 1/Arm 2: Placebo
n=6 participants at risk
Placebo comparator
|
Part 2/Arm 1 of Study: S. Sonnei 53G
n=10 participants at risk
10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) given 53G S. sonnei
|
Part 2/Arm 2 of Study: S Sonnei 53G (Controls)
n=10 participants at risk
10 subjects (naïve controls) given S. sonnei 53G
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrheic stool
|
15.4%
2/13 • Number of events 2 • 4 months
|
66.7%
4/6 • Number of events 4 • 4 months
|
40.0%
4/10 • Number of events 4 • 4 months
|
20.0%
2/10 • Number of events 2 • 4 months
|
|
Gastrointestinal disorders
Water stool
|
15.4%
2/13 • Number of events 2 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
60.0%
6/10 • Number of events 6 • 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • 4 months
|
33.3%
2/6 • Number of events 2 • 4 months
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.7%
1/13 • Number of events 1 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Nervous system disorders
Headache
|
61.5%
8/13 • Number of events 8 • 4 months
|
33.3%
2/6 • Number of events 2 • 4 months
|
40.0%
4/10 • Number of events 4 • 4 months
|
20.0%
2/10 • Number of events 2 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Tenderness at digit of left foot
|
7.7%
1/13 • Number of events 1 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • 4 months
|
0.00%
0/6 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Immune system disorders
Urticaria
|
7.7%
1/13 • Number of events 1 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Psychiatric disorders
Insomnia (sleep difficulty)
|
7.7%
1/13 • Number of events 1 • 4 months
|
0.00%
0/6 • 4 months
|
20.0%
2/10 • Number of events 2 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Injury, poisoning and procedural complications
Abrasion wound at peri-anal
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/13 • 4 months
|
33.3%
2/6 • Number of events 2 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Gastrointestinal disorders
Lower abdominal pain
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia at back
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Gastrointestinal disorders
Abdominal pain (epigastrium)
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
20.0%
2/10 • Number of events 2 • 4 months
|
30.0%
3/10 • Number of events 3 • 4 months
|
|
General disorders
Feverish
|
23.1%
3/13 • Number of events 3 • 4 months
|
0.00%
0/6 • 4 months
|
20.0%
2/10 • Number of events 2 • 4 months
|
30.0%
3/10 • Number of events 3 • 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus at left thigh
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Gastrointestinal disorders
Abdominal pain (generalized)
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Tenesmus
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
20.0%
2/10 • Number of events 2 • 4 months
|
|
General disorders
Malaise
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
30.0%
3/10 • Number of events 3 • 4 months
|
20.0%
2/10 • Number of events 2 • 4 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/13 • 4 months
|
16.7%
1/6 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
0.00%
0/10 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal swelling
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia at neck
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
40.0%
4/10 • Number of events 4 • 4 months
|
40.0%
4/10 • Number of events 4 • 4 months
|
|
Gastrointestinal disorders
Dysentery
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
30.0%
3/10 • Number of events 3 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
General disorders
Fatigue
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
30.0%
3/10 • Number of events 3 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
20.0%
2/10 • Number of events 2 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Chills
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
20.0%
2/10 • Number of events 2 • 4 months
|
0.00%
0/10 • 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
20.0%
2/10 • Number of events 2 • 4 months
|
0.00%
0/10 • 4 months
|
|
Infections and infestations
Herpes (lip)
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Gastrointestinal disorders
Abdominal pain (whole)
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Investigations
High ALT
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Aphthous
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Injury, poisoning and procedural complications
Tendinitis
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Increased bowel sound
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Perianal abscess
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Infections and infestations
Shigellosis
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia at right shoulder
|
0.00%
0/13 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
Additional Information
Punnee Pitisutithum, MBBS, DTM&H, FRCPT
Vaccine Trial Treatment Center, Mahidol University
Phone: 66-2-643-5599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place